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Josh replied to the topic "CRO or Big Pharma" – 4 years, 11 months ago
Keep in mind that pharma trials are very different from device trials, i.e. Phase I, II, II vs. no phases. The larger CRO’s can do both types, but there are smaller ones that specialize in one or the other.
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Josh replied to the topic "Discussion Topic: The Fifth "P" of Marketing" – 4 years, 11 months ago
Keep in mind here that Participation always involves a two-way communication, over whatever media. Product placement, exclusive content, etc. and ads are all “push media” because they are one-way.
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Josh replied to the topic "Marketing Strategy" – 4 years, 11 months ago
One trend to be aware of on these forums is the asking of questions to the class and not giving your own answer or opinion on the matter. That is not something that takes thought or substantive construction of ideas…. Read more»
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Josh replied to the topic "Medical Device SWOT Analysis" – 4 years, 11 months ago
What company would you choose to analyze, alexandrabuga?
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Josh replied to the topic "Discussion Topic: Antibiotic-Releasing Hip Stem" – 4 years, 11 months ago
We will learn later than an IDE is required for any clinical trial that poses significant risk, and usually this means that if you change the standard of care for a patient in the clinical trial, it is significant risk… Read more»
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Josh replied to the topic "Discussion Topic: e-cigarettes" – 4 years, 11 months ago
So given the content for this week, let’s think about this. Some of you are saying, and pointing out, that e-cigs are drug delivery devices rightfully regulated by the FDA. If this is a Class III device, it would mean… Read more»
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Josh replied to the topic "Discussion Topic: Beyond experimental design issues" – 4 years, 11 months ago
Right, so the underlying message there is that CRO’s are businesses that want to maximize their turnover. The more studies they do, the more money they make. How is the situation different in a university? Obviously they also want to… Read more»
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Josh replied to the topic "Discussion Topic: Beyond experimental design issues" – 4 years, 11 months ago
Some great points made above, yes. You see some of the pitfalls that have happened with favoring close connections over sound business decisions, but as some of you correctly point out, the sound business decisions are not clear-cut either. *… Read more»
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Josh replied to the topic "Discussion Topic: Project Management in a medical device setting" – 4 years, 11 months ago
That is an excellent point. What happens many times is the project is broken up into sections. There’s a general product development project, and then several separate regulatory projects hooked onto it, one for each country or region. You will… Read more»
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Josh replied to the topic "Simulations" – 4 years, 11 months ago
Definitely a good question, especially since either scenario could occur in real life: you could be working on a remote team, or working in an office every day. In either case, you would need to be able to do this… Read more»
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Josh replied to the topic "Discussion Topic: Course conclusion and impressions" – 4 years, 11 months ago
I would like to thank everyone for the great feedback. It confirms for me that the reason why I made this course and the way in which I designed it are benefiting people. You were a good group. One point… Read more»
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Josh replied to the topic "Discussion Topic: Course conclusion and impressions" – 4 years, 11 months ago
That’s an interesting comment which got my attention because it is different from some of the others. What other names or verbiage in the description would make it more accurate? Tell me more.
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Josh replied to the topic "Risk management and Labels" – 4 years, 11 months ago
Think about a medical device being used during a surgery. The surgeon is scrubbed in and working on the patient. The techs in the OR are following the surgeon’s instructions to hand things over, rinse things off, etc. At what… Read more»
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Josh replied to the topic "Risk analysis in real company" – 4 years, 11 months ago
Would you be able to share with us some of the differences you see between Medical Device and Pharma risk management structure and technique?
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Josh replied to the topic "Discussion Topic: Supplemental on DHF and DMR" – 4 years, 11 months ago
The last post here is the most accurate. Design Controls are not “needed” in the EU in the sense that they are not mandated by a regulatory body like they are in the US. Granted, it is still a good… Read more»
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Josh replied to the topic "Important Part of DDP" – 4 years, 11 months ago
As I may have mentioned in the lecture, the DDP for most companies is just a boiler plate document that gets filled in, and pretty much remains the same throughout the project. What I am trying to teach here and… Read more»
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Josh posted a new topic "Discussion Topic: Outsource vs. Insource the clinical trial" – 4 years, 11 months ago
Every single task from the moment a clinical trial is conceived to the moment it is submitted to the FDA with complete data as part of a larger submission may be handled by a company or a consultant. There are… Read more»
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Josh posted a new topic "Discussion Topic: Scope creep….when your project changes" – 4 years, 11 months ago
….and not always for the better. Using what you have learned in the Scope Management lecture, what situations have you encountered where a project suffered from scope creep? What did you do in that situation? What did you do right?… Read more»
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Josh posted a new topic "Discussion Topic: Costs and managing your investment" – 4 years, 11 months ago
Net present value is the calculation that compares the amount invested today to the present value of the future cash receipts from the investment. In other words, the amount invested is compared to the future cash amounts after they are… Read more»
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Josh posted a new topic "Discussion Topic: Risk Analysis methods" – 4 years, 11 months ago
Depending on the project, a number of different risk analysis methods are available, but like anything, none of them are perfect. If one of them was, the product that used that method would never have issues but reading the headlines… Read more»
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